Contact Information
Address:
2160 W State Road 434, Longwood, FL 32779
Phone:
Website
https://503bcompoundingpharmacy.com/
503B Compounding Pharmacy is an FDA-registered outsourcing facility operating under Section 503B of the Federal Food, Drug, and Cosmetic Act, providing large-scale, sterile compounded medications to healthcare systems across the United States. The pharmacy is built to serve hospitals, surgery centers, clinics, and licensed healthcare providers that require consistent, compliant, and scalable access to compounded pharmaceuticals without patient-specific prescriptions. Operating from its facility at 2160 W State Road 434, Longwood, FL 32779, 503B Compounding Pharmacy follows current Good Manufacturing Practice (cGMP) standards and is subject to routine FDA inspection. This places it in a fundamentally different category than traditional 503A pharmacies. The focus is not retail compounding or one-off prescriptions. The focus is controlled production, batch consistency, sterility assurance, and regulatory discipline. The facility specializes in sterile injectable and non-sterile compounded medications designed to address drug shortages, support procedural efficiency, and improve supply chain reliability for healthcare providers. All production is performed in ISO-classified cleanroom environments using validated processes, documented quality systems, and lot-level traceability. Each batch undergoes appropriate sterility, endotoxin, and potency testing based on risk level and formulation requirements. 503B Compounding Pharmacy prioritizes transparency and compliance over speed or marketing claims. Products are compounded using USP-grade ingredients sourced from vetted suppliers, with full documentation available for healthcare partners. Beyond production, the pharmacy supports client institutions with regulatory documentation, recall readiness, adverse event reporting protocols, and consistent supply planning. The company exists to solve real operational problems for healthcare organizations. Drug shortages, inconsistent manufacturers, and unreliable distributors create risk for patient care. A properly run 503B facility reduces that risk by acting as a compliant, predictable manufacturing partner rather than a reactive supplier.
2160 W State Road 434, Longwood, FL 32779
https://503bcompoundingpharmacy.com/
503B Compounding Pharmacy operates as an FDA-registered outsourcing facility in strict compliance with Section 503B of the Federal Food, Drug, and Cosmetic Act. This 503B Compounding Pharmacy is situated at 2160 W State Road 434, Longwood, FL 32779. The 503B Compounding Pharmacy model represents a significant advancement in the compounding field, adhering to the highest standards of pharmaceutical production. As a 503B outsourcing facility, this 503B Compounding Pharmacy is subject to rigorous FDA oversight, including current Good Manufacturing Practice (cGMP) regulations, which are the same standards applied to large-scale pharmaceutical manufacturers. This ensures that every preparation leaving the 503B Compounding Pharmacy meets exceptional standards of quality, purity, and strength.
The core function of this 503B Compounding Pharmacy is the large-scale production of compounded sterile preparations (CSPs) for office use by healthcare practitioners. The 503B Compounding Pharmacy provides physicians, surgeons, veterinarians, and other medical professionals with access to a reliable supply of high-quality, sterile medications that are often in short supply or unavailable from traditional pharmaceutical manufacturers. By serving the medical community from its location at 2160 W State Road 434, Longwood, FL 32779, this 503B Compounding Pharmacy plays a vital role in supporting patient care. The 503B Compounding Pharmacy’s operations are designed for volume, efficiency, and consistency, providing practitioners with the assurance that the medications they need will be available when required for procedures and treatments.
Patients benefit indirectly from the services of the 503B Compounding Pharmacy through their trusted healthcare providers. When a medical professional utilizes medications sourced from this 503B Compounding Pharmacy, they can be confident in the product's integrity. The 503B Compounding Pharmacy’s commitment to cGMPs means every batch is produced in a controlled, monitored environment with extensive documentation and testing protocols. This level of quality control at the 503B Compounding Pharmacy minimizes the risk of contamination and ensures dosage accuracy. For healthcare providers practicing near 2160 W State Road 434, Longwood, FL 32779, having a local 503B Compounding Pharmacy as a resource is invaluable for maintaining a consistent and safe medication supply for their practice.
The team at the 503B Compounding Pharmacy comprises skilled pharmacists and technicians who are experts in sterile compounding techniques and regulatory compliance. Their expertise is fundamental to the 503B Compounding Pharmacy's mission of producing safe and effective medications. The 503B Compounding Pharmacy is equipped with state-of-the-art technology and environmental controls to maintain the sterility of its cleanrooms throughout the production process. This dedication to excellence is a hallmark of a true 503B outsourcing facility. For more information about the 503B Compounding Pharmacy and its services, please visit the official website at https://503bcompoundingpharmacy.com/ or contact the facility directly at (407)993-1381.
FAQ
What does it mean that this is a 503B Compounding Pharmacy?
It means this facility is an FDA-registered outsourcing facility that compounds large volumes of sterile medications for office use under Section 503B of the Federal Food, Drug, and Cosmetic Act. The 503B Compounding Pharmacy adheres to strict current Good Manufacturing Practice (cGMP) regulations enforced by the FDA.
Who can order from the 503B Compounding Pharmacy at 2160 W State Road 434?
The 503B Compounding Pharmacy provides compounded medications for office use to licensed healthcare practitioners, including physicians, surgeons, dentists, and veterinarians. The 503B Compounding Pharmacy does not typically dispense medications directly to individual patients based on a prescription.
What types of medications does this 503B Compounding Pharmacy produce?
This 503B Compounding Pharmacy specializes in producing compounded sterile preparations (CSPs), which can include injectables, IV bags, ophthalmics, and other medications required by healthcare professionals for use in their practices located near 2160 W State Road 434, Longwood, FL 32779.
How does the 503B Compounding Pharmacy ensure medication safety?
As a 503B outsourcing facility, this 503B Compounding Pharmacy follows rigorous cGMP protocols. This includes environmental monitoring, validated processes, stringent quality control testing, and comprehensive documentation for every batch produced to ensure sterility, potency, and purity.
How can a healthcare provider start ordering from this 503B Compounding Pharmacy?
Healthcare providers interested in the services of the 503B Compounding Pharmacy can initiate the process by contacting the facility directly at (407)993-1381 or by visiting the website at https://503bcompoundingpharmacy.com/ to discuss their practice's specific needs and establish an account.